Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty

NCT07380399 | Recruiting DMC

• 1 other identifier: 21171-01/12/2025
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 2

Brief Summary

Coronary angiography and angioplasty are commonly performed through the radial artery at the wrist as this approach is associated with fewer bleeding complications and faster recovery. In some patients, the radial artery becomes occluded after prior procedures, requiring selection of an alternative access site for future coronary interventions. The ulnar artery is a potential alternative wrist access. However, limited data are available on the safety of using the ulnar artery in the same arm as an occluded radial artery and on the possible effects on hand strength, sensation, and daily hand function. The goal of this observational study is to evaluate the safety of transulnar access and its effect on hand function in adults with ipsilateral radial artery occlusion undergoing coronary angiography or angioplasty. The main questions addressed by the study are:

• How often do serious access-related vascular or nerve complications occur?
• Does hand strength, sensation, or functional use of the hand change during follow-up?
• Does the ulnar artery remain patent after the procedure? The choice of vascular access site is made by the treating physician based on clinical judgment. Participants who undergo transulnar access will undergo follow-up assessments, including ultrasound evaluation of arm arteries, standardized hand function testing, and short questionnaires assessing upper-limb function. The findings of this study are expected to inform access-site selection, improve patient counseling, and support safer care for patients with radial artery occlusion undergoing coronary procedures.

Conditions

Vascular Access; Coronary Artery Disease (CAD); Radial Artery Occlusion

Keywords

Radial Artery Occlusion; Ulnar Artery; Coronary Angiography; Percutaneous Coronary Intervention; Upper Limb Function; Transulnar Access

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications

  Composite incidence of serious vascular and clinical neuromuscular complications attributable to transulnar arterial access ipsilateral to radial artery occlusion. Serious vascular events include acute hand ischemia, symptomatic ulnar artery occlusion, flow-limiting dissection requiring treatment, pseudoaneurysm or arteriovenous fistula requiring intervention, major access-site hematoma, or major bleeding. Clinical neuromuscular events include new, clinically evident motor or sensory deficits in the ulnar nerve distribution that persist or require targeted therapy.

  30 days

Secondary Outcomes (10)

• Number of Access Attempts

  During the index procedure

• Technical Success Without Access-Site Crossover

  During the index procedure

• Procedure Duration

  During the index procedure

• Ulnar Artery Patency

  Within 24 hours, 30 days, and 180 days

• Early Access-Related Vascular and Neuromuscular Complications

  Within 24 hours after band removal

Study Arms (1)

ULNART Cohort

Adults with documented radial artery occlusion undergoing elective coronary angiography or angioplasty, in whom transulnar arterial access ipsilateral to the occluded radial artery is selected by the treating physician. Participants are followed prospectively to assess vascular safety and hand function outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from cardiac catheterization laboratories and cardiology services of two tertiary-care public hospitals in Greece, including high-volume referral centers performing invasive coronary procedures. The study population represents adults undergoing routine elective coronary angiography or angioplasty in these hospital settings, where vascular access decisions are made as part of standard clinical practice.

You may qualify if:

• Participants must meet all of the following criteria to be eligible:
• Adults aged 18 years or older
• Documented radial artery occlusion in the upper limb intended for vascular access, confirmed by ultrasound or angiography
• Scheduled to undergo elective coronary angiography and/or angioplasty
• Transulnar arterial access on the same side as the occluded radial artery is selected by the treating physician
• Contralateral radial artery access is not feasible or is clinically undesirable, including for reasons such as:
• documented occlusion or severe disease of the contralateral radial artery
• unfavorable anatomy or prior failed access
• strategic preservation of the contralateral radial artery for future surgical or dialysis needs
• Adequate ulnar artery flow and anatomy for access, as assessed by pre-procedural ultrasound
• Able and willing to provide written informed consent

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Inadequate or absent ulnar artery flow at the intended access site on ultrasound
• Known ulnar nerve injury or neuropathy affecting the access-side upper limb
• Severe pre-existing motor or sensory dysfunction of the access-side hand that would interfere with functional assessment
• Emergency coronary procedures that preclude baseline vascular or functional assessment
• Participation in another interventional clinical study involving vascular access or intervention in the same upper limb
• Local conditions at the intended access site, such as active infection, burn, or extensive scarring
• Pregnancy or breastfeeding
• Life expectancy less than 6 months

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

Hellenic Red Cross Hospital

Athens, Greece

RECRUITING

Hippokratio General Hospital

Athens, Greece

RECRUITING

Related Publications (10)

• Roghani-Dehkordi F, Hosseinzadeh H, Kermani-Alghoraishi M, Khosravi A, Vakhshoori M, Sadeghi M, Danesh M, Sadeghi N, Sahfie D. The transulnar approach in the patients with ipsilateral radial artery occlusion. ARYA Atheroscler. 2020 Jan;16(1):33-38. doi: 10.22122/arya.v16i1.2016.

  PMID: 32499829 BACKGROUND

• Hsueh SK, Cheng CI, Fang HY, Omran MM, Liu WH, Chung WJ, Chen CJ, Yang CH, Fang CY, Wu CJ. Feasibility and Safety of Transulnar Catheterization in Ipsilateral Radial Artery Occlusion. Int Heart J. 2017 May 31;58(3):313-319. doi: 10.1536/ihj.16-244. Epub 2017 May 12.

  PMID: 28496021 BACKGROUND

• Kedev S, Zafirovska B, Dharma S, Petkoska D. Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E51-60. doi: 10.1002/ccd.25123. Epub 2013 Aug 5.

  PMID: 23832623 BACKGROUND

• Duarte PVF, Cortes LA, de Almeida Sampaio FB, Barroso JM, da Silveira GM, Nascif GB, Filho AO, Ribeiro ML, Salles MM, De Lorenzo A. Feasibility and Safety of Ipsilateral Ulnar Access in Cases of Impossibility or Failure of Radial Access for Coronary Angiography or Percutaneous Coronary Intervention. J Invasive Cardiol. 2022 Feb;34(2):E92-E97. doi: 10.25270/jic/21.00138. Epub 2022 Jan 16.

  PMID: 35037897 BACKGROUND

• Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.

  PMID: 31753298 BACKGROUND

• Hahalis G, Aznaouridis K, Tsigkas G, Davlouros P, Xanthopoulou I, Koutsogiannis N, Koniari I, Leopoulou M, Costerousse O, Tousoulis D, Bertrand OF. Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis. J Am Heart Assoc. 2017 Aug 23;6(8):e005430. doi: 10.1161/JAHA.116.005430.

  PMID: 28838915 BACKGROUND

• Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.

  PMID: 35595672 BACKGROUND

• Zwaan EM, Cheung ES, IJsselmuiden AJJ, Holtzer CAJ, Schreuders TAR, Kofflard MJM, Coert JH. Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial. J Interv Cardiol. 2022 Sep 6;2022:6858962. doi: 10.1155/2022/6858962. eCollection 2022.

  PMID: 36128073 BACKGROUND

• Valgimigli M, Campo G, Penzo C, Tebaldi M, Biscaglia S, Ferrari R; RADAR Investigators. Transradial coronary catheterization and intervention across the whole spectrum of Allen test results. J Am Coll Cardiol. 2014 May 13;63(18):1833-41. doi: 10.1016/j.jacc.2013.12.043. Epub 2014 Feb 26.

  PMID: 24583305 BACKGROUND

• Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.

  PMID: 29665617 BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis

Study Officials

• Konstantinos Aznaouridis, Ass. Professor of Cardiology

  1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Dimitrios Karelas, MD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Ioannis Tsiafoutis, MD, PhD

  2nd Department of Cardiology, Hellenic Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Karelas, MD

CONTACT

+30 698 6428463; dim.f.karelas@gmail.com

Konstantinos Aznaouridis, Ass. Professor of Cardiology

CONTACT

+30 697 2024534; conazna@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 2, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GR (2)